The first effort to gain approval for a biosimilar monoclonal antibody in Europe is being felt in the Philadelphia region.

Biosimilars are officially approved subsequent versions of biologic medical products [drugs made by a living organism or derived from a living organism] developed by a different sponsor after the drug’s patent expired. In the United States, the Food and Drug Administration has issued a series of guidelines over the past two for companies seeking approval of biosimilar products, but the agency has yet to approve any.

Europe approved its first biosimilar medicine in 2006.

A committee of the European Medicines Agency on Friday recommended approval of the first two monoclonal antibody biosimilars with the same active ingredient as Remicade, a rheumatoid arthritis drug developed by Centocor, now Janssen Biotech of Horsham, Pa. Remicade has generated billion of dollars of revenues, including more than $1.8 billion lat year, since it was approved in 1998.

Monoclonal antibodies are structurally complex substances that can locate and bind to specific molecules.

The EMA's Committee for Medicinal Products for Human Use recommended granting marketing authorization to Remsima and Inflectra, which both contain the same known active substance: infliximab. Infliximab binds to tumour necrosis factor alpha, a protein promoting inflammatory response that causes many of the clinical problems associated with autoimmune disorders.

The applicant for Remsima is from Celltrion Healthcare Hungary. The applicant for Inflectra is Hospira UK Ltd.

Remsima and Inflectra are recommended for use in the same indications as Remicade, which has been sold in Europe since 1999. Those indications cover a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.

In response to the committee’s recommendation, Janssen Biotech issued a statement saying it “has long supported a defined pathway for biosimilars that ensures patient safety and expands access to these medicines. We remain committed to ensuring health care professionals and patients continue to have access to Remicade, a biologic that has been used in the treatment of more than 1.8 million patients worldwide across multiple inflammatory diseases, and has established a positive benefit-risk profile through more than 20 years of clinical and real-world experience.”
Janssen is a subsidiary of Johnson & Johnson (NYSE:JNJ).